Text Messaging Adherence to Stimulant Medication | NCT01967485

Studies
Text Messaging Adherence to Stimulant Medication

NCT01967485

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Text- Messaging
Treatment as usual

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Aug 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Oct 18, 2013

First Submission Date that Met QC Criteria

Oct 22, 2013

First Posted Date

Oct 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2017

Last Update Posted Date

Feb 23, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mai Uchida, Child Psychiatrist, Pediatric Psychopharmacology and Adult ADHD Program, Massachusetts General Hospital; Instructor in Psychiatry, Harvard Medical School, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
American Academy of Child Adolescent Psychiatry.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if an individualized text messaging intervention for the parents of children with Attention Deficit/Hyperactivity Disorder is effective in improving medication adherence and disease management.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Text Messaging	Experimental	Text messaging to the parents of children. Children will receive open treatment for Attention Deficit/Hyperactivity Disorder (ADHD) with stimulant medication.	Other: Text- Messaging Other: Treatment as usual
No Text Messaging	Active Comparator	Children will receive open treatment for ADHD with stimulant medication. This group will not get the text messaging intervention, but will receive treatment as usual.	Other: Treatment as usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Text- Messaging	Other	Text messages will be sent to the parents of children enrolled in the study.	Text Messaging

Measure	Description	Time Frame
Medication Adherence	Adherence to the individualized medication regimen	Six Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female children ages 6-17 years
A diagnosis of ADHD (inattentive, hyperactive/impulsive, or combined type) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) based on clinical assessment and supported by a Clinical Global Impression- ADHD (CGI-ADHD) Severity Score of at least 4 (Moderately Ill)
Has a parent in possession of a cellular phone with text messaging capabilities and is interested in and willing to receive planned text messages
Has never been treated with stimulant medication, or has begun treatment with stimulant medication within three months of study enrollment.

Exclusion Criteria:

Any serious, unstable, chronic medical condition, per clinician assessment
Cardiovascular disease
Current or past history of seizures
Treatment with stimulant medication beyond three months prior to enrollment
Pregnant or nursing females
Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
Unstable psychiatric illness other than ADHD, including, but not limited to: Autism, Bipolar Disorder, Psychosis, Major Depressive Disorder, Anorexia, Bulimia, Post-Traumatic Stress Disorder and Anxiety Disorders
History of multiple adverse drug reactions
Presence of suicidal risk, or homicidality
Unwilling/unable to comply with study procedures
Poor command of the English language

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Mai Uchida, MD	Massachusetts General Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D055118	Medication Adherence

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D010349	Patient Compliance

Browse Leaves

Not provided

Browse Branches

Not provided